Vascular Malformations and Abnormalities of Growth
Primary Purpose
Abnormality
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
skin biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Abnormality focused on measuring vascular malformation, vascular anomalies, abnormalities of growth, overgrowth, subjects with vascular malformations abnormalities of growth.
Eligibility Criteria
Inclusion Criteria:
- Greater than 1 year of age
- Diagnosis of vascular malformation
- Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation given they have the cognitive capacity to do so.
Exclusion Criteria:
- Patients less than 1 year of age
- Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring
- Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy
Sites / Locations
- Childrens Hospital of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single group single arm study
Arm Description
Open no masking is used. All involved know the identity of the intervention assignment
Outcomes
Primary Outcome Measures
Percent of growth over time
Secondary Outcome Measures
Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.
Full Information
NCT ID
NCT01105676
First Posted
April 15, 2010
Last Updated
January 6, 2014
Sponsor
Medical College of Wisconsin
Collaborators
Children's National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01105676
Brief Title
Vascular Malformations and Abnormalities of Growth
Official Title
Vascular Malformations and Abnormalities of Growth
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's National Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To take part in this study you/your child have a vascular malformation, a type of blood vessel disorder whose cause is unknown.
The investigators will do this by looking at changes in the genes and proteins in the cells of the malformation as well as normal cells.
The investigators are doing this research because currently there is no known cause of vascular malformations and no way to know whether or not other health problems will occur in addition to the malformation. Through this research we hope to create standard methods for doctors to examine and treat people with vascular anomalies.
Detailed Description
If you/your child agree to participate
Informed consent and permission to use or disclose you/your child's health information for reserve purposes will be obtained by the research team. You will receive a copy of the consent form.
You/your child will be examined by a physician from the research team and interviewed about your medical background and condition every year for five years.
You/your child will have photographs taken of the affected area at each visit.
You/your child will have two, one time biopsies or skin samples taken by a dermatologist. Skin areas will be numbed with lidocaine and a 4 or 5 millimeter (or approximately 0.15 to 0.19 inch) sample will be taken in two different locations. The dermatologist taking the skin sample will use every effort to choose an area that can be covered by clothing or kept out of sight to others. The doctor will either use gelfoam or one stitch/suture per biopsy to seal off the area, which helps with healing and preventing bleeding. If a stitch is placed in the biopsy site, another visit about 7-10 days following the procedure will be necessary to remove the stitch.
5. You may still participate in the study if you consent to having only one biopsy taken of your affected (lesion) skin and not one of your unaffected (normal) skin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormality
Keywords
vascular malformation, vascular anomalies, abnormalities of growth, overgrowth, subjects with vascular malformations abnormalities of growth.
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single group single arm study
Arm Type
Experimental
Arm Description
Open no masking is used. All involved know the identity of the intervention assignment
Intervention Type
Procedure
Intervention Name(s)
skin biopsy
Intervention Description
Two skin biopsies will be taken one time
Primary Outcome Measure Information:
Title
Percent of growth over time
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Greater than 1 year of age
Diagnosis of vascular malformation
Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation given they have the cognitive capacity to do so.
Exclusion Criteria:
Patients less than 1 year of age
Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring
Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Duffy, MD
Organizational Affiliation
Children's Hospital and Health System Foundation, Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vascular Malformations and Abnormalities of Growth
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